Masterstudiengang "Drug Regulatory Affairs"

The purpose of this master thesis is to provide an overview of the regulatory situation of herbal medicinal products in the European Union, the United States and Japan. The regulatory environment regarding these products in the three ICH regions will be compared and it will be discussed if there is a need for harmonisation.

Evaluation of herbal therapy is steadily growing more positive worldwide. As herbal medicinal products are generally regarded as safe and gentle and are used in the treatment of chronic pain, their market share increases in a world where the society ages and more chronic patients exist. But the differences in the regulation of these products in the three ICH regions are enormous.

Most herbal medicinal products that exhibit any pharmacological function are considered to be medicines in Europe and the same requirements as for synthetic drugs apply. But nevertheless there exist various exemptions from this rule in the Member States. Consequently, national registration instead of the mutual recognition is the preferred way of companies in order to bring herbal medicinal products to the market. The harmonisation process in the EU will be promoted in the near future by the impact of various measures like the implementation of the new Directive on traditional medicinal products, a new guideline on defining “serious risk to public health” and updating of some EMEA guidelines.

In the United States and Japan the categories of dietary supplements and also medical food are predominantly used for herbal medicinal products, whereas only few are regulated under drug law. Only some exemptions for herbal medicinal products exist from the burdensome way of drug approval in the United States but no specific category for well-known plants or traditionally used herbal products exists as in the EU. The easiest way for foreign companies to place a product on the market in the United States and Japan is via the food or dietary supplement market.

Harmonisation and improvement in the process of herbal medicinal product regulation is needed, so that those products with sufficient scientific data to support claims of safety and therapeutic efficacy can choose the way of market authorisation under drug law. Bibliographical applications and traditional registrations, which make the European market more hospitable to natural remedies, may provide an opportunity to open the drug market in the United States and Japan also for products with well-established and long traditional use. Ensuring safety and quality of the products will be the benefit of a market authorisation as a drug compared to the status of dietary supplement not only in the consumers point of view.